Predictors of response to full agonist opioids in enriched enrollment randomized withdrawal clinical trials: a participant-level data meta-analysis.

This study aims to identify predictors of success in treating chronic pain patients with full agonist opioids by analyzing harmonized individual patient data from 5594 participants in 9 enriched enrollment randomized withdrawal clinical trials available in the Food and Drug Administration data repository. We analyzed both the participants' success with titration and continued success in the 84-day maintenance phases after randomization for those maintained on the drug. We used the full data set to assess participant demographics and subsets of data containing participant reported outcomes at baseline.

Predictors of successful initiation of buprenorphine in enriched enrollment randomized withdrawal clinical trials in both opioid experienced and naïve participants: a participant-level meta-analysis.

Introduction: No prediction models exist for the success for buprenorphine initiation in opioid-naïve patients or in transition from other opioids in patients treated for chronic pain.

Objectives: To create a prediction model for the successful use of buprenorphine to treat chronic pain.

Methods: Stepwise Akaike information criterion prediction modeling procedures were applied to a harmonized participant-level data set of 10 enriched enrollment randomized withdrawal clinical trials of buprenorphine submitted to the Food and Drug Administration.

Risk factors for household colonization by extended-spectrum cephalosporin-resistant enterobacterales (ESCrE) in Botswana.

Background: The epidemiology of community colonization with extended-spectrum cephalosporin-resistant Enterobacterales (ESCrE) in low- and middle-income countries (LMICs) is largely uncharacterized. In the community, the household is of particular importance. Identifying risk factors for household ESCrE colonization is critical to inform antibiotic resistance reduction strategies.

Minimum clinically important differences in acute pain: a patient-level re-analysis of randomized controlled analgesic trials submitted to the US Food and Drug Administration.

The lack of established minimum clinically important differences in acute pain has made it challenging to interpret efficacy in analgesic trials. We performed a patient-level re-analysis of double-blind, placebo-controlled trials submitted to the US Food and Drug Administration to estimate minimum clinically important differences in acute postoperative pain. Trials were categorized by acute surgical pain model: dental extraction, bunionectomy, orthopedic surgery, and soft tissue surgery.

Association of HIV status with infections complicating abortion in Botswana.

Women with HIV (WWH) were found to have an increased risk of abortion-related infection relative to women without HIV (WWoH) and those without HIV status documented. This relationship persisted even after accounting for factors such as mechanical injury on pelvic examination, a marker of the least safe methods of self-induction. Whether this complication in WWH is because of immunocompromise or behavioral characteristics requires additional investigation.

Do relationships between ambient temperature and serious adverse health outcomes vary among users of different antidiabetes drugs? A retrospective cohort study of US Medicaid beneficiaries with type 2 diabetes.

Objective: Prior studies demonstrate that some untoward clinical outcomes vary by outdoor temperature. This is true of some endpoints common among persons with diabetes, a population vulnerable to climate change-associated health risks. Yet, prior work has been agnostic to the antidiabetes drugs taken by such persons.

Concomitant Use of Oral Anticoagulants With Oral Dipeptidyl Peptidase-4 Inhibitors and Serious Bleeding Events.

In a prior screening study, saxagliptin, a dipeptidyl peptidase-4 inhibitor (DPP-4i), was found to have an increased rate of serious bleeding when used concomitantly with several oral anticoagulants (OACs). We aimed to confirm or refute the associations between concomitant use of individual OACs and DPP-4is and serious bleeding in a large US database, using self-controlled case series (SCCS) and case-crossover (CCO) designs. The study population was eligible Medicare beneficiaries co-exposed to a DPP-4i (precipitant) and either an OAC (object drug) or lisinopril (negative control object drug) in 2016-2020.

Prolonged Inotrope Use After Surgery for Congenital Heart Disease: A Common Occurrence with a High Burden of Mortality.

Outcomes in patients requiring prolonged inotropes (PI) following surgery for congenital heart disease (CHD) have not been well studied. We aimed to describe the burden of PI use in the immediate postoperative period after CHD surgery and identify risk factors for in-hospital mortality. We conducted a retrospective cohort study using the Pediatric Health Information System® (PHIS) database.

Spending Analysis of Machine Learning-Based Communication Nudges in Oncology.

Background: Serious illness conversations (SICs) in the outpatient setting may improve mood and quality of life among patients with cancer and decrease aggressive end-of-life care. Interventions informed by behavioral economics may increase rates of SICs between oncology clinicians and patients, but the impact of these interventions on end-of-life spending is unknown.

Methods: This study is a secondary analysis of a stepped-wedge cluster randomized, controlled trial that involved nine medical oncology practices and their high-risk patients at a large academic institution between June 2019 and April 2020.

Thinking Three-Dimensionally: A Self- and Externally-Controlled Approach to Screening for Drug-Drug-Drug Interactions Among High-Risk Populations.

The global rise in polypharmacy has increased both the necessity and complexity of drug-drug interaction (DDI) assessments, given the growing potential for interactions involving more than two drugs. Leveraging large-scale healthcare claims data, we piloted a semi-automated, high-throughput case-crossover-based approach for drug-drug-drug interaction (3DI) screening. Cases were direct-acting oral anticoagulant (DOAC) users with either a major bleeding event during ongoing dispensings for potentially interacting, enzyme-inhibiting antihypertensive drugs (AHDs) (Study 1), or a thromboembolic event during ongoing dispensings for potentially interacting, enzyme-inducing antiseizure medications (ASMs) (Study 2).

Comparative Risk of Injury with Concurrent Use of Opioids and Skeletal Muscle Relaxants.

Concurrent use of skeletal muscle relaxants (SMRs) and opioids has been linked to an increased risk of injury. However, it remains unclear whether the injury risks differ by specific SMR when combined with opioids. We conducted nine retrospective cohort studies within a US Medicaid population.

Impact of deceased organ donor marijuana use on donor culture positivity and solid organ transplant recipient outcomes.

With the increasing prevalence of marijuana use in the US, many deceased organ donors have a history of marijuana use, raising concerns about infectious risks to transplant recipients. We performed a multicenter retrospective cohort study in which exposed donors were those with recent marijuana use (in the prior 12 months) and unexposed donors were those with no recent marijuana use. Primary outcomes included the following: (1) positive donor cultures for bacteria or fungi, (2) recipient infection due to bacteria or fungi within 3 months posttransplant, and (3) recipient graft failure or death within 12 months posttransplant.

Antibiotic Prescribing Patterns for Respiratory Tract Illnesses Following the Conclusion of an Education and Feedback Intervention in Primary Care.

Background: A study previously conducted in primary care practices found that implementation of an educational session and peer comparison feedback was associated with reduced antibiotic prescribing for respiratory tract diagnoses (RTDs). Here, we assess the long-term effects of this intervention on antibiotic prescribing following cessation of feedback.

Methods: RTD encounters were grouped into tiers based on antibiotic prescribing appropriateness: tier 1, almost always indicated; tier 2, possibly indicated; and tier 3, rarely indicated.

Performance of CHROMagar ESBL media for the surveillance of extended-spectrum cephalosporin-resistant (ESCrE) from rectal swabs in Botswana.

Lack of laboratory capacity hampers consistent national antimicrobial resistance (AMR) surveillance. Chromogenic media may provide a practical screening tool for detection of individuals colonized by extended-spectrum beta-lactamase (ESBL)-producing organisms. CHROMagar ESBL media represent an adequate screening method for the detection of extended-spectrum cephalosporin-resistant (ESCrE), isolated from rectal swabs.

Unique characteristics of end-of-life hospitalizations in Parkinson disease.

Introduction: Persons with Parkinson disease (PD) are hospitalized at higher rates, have longer lengths of stay, and are more likely to die in the hospital than age-matched peers. Although prior studies have compared inpatient outcomes between persons with and without PD, little is known about inpatient outcomes across the PD trajectory, or whether hospitalizations occurring in the last 6 months of life differ from earlier hospitalizations.

Methods: This cross-sectional study compared Medicare Part A and B beneficiaries aged 65 and older with a qualifying PD diagnosis who were hospitalized in 2017: decedents who died between 7/1/2017 and 12/31/2017 from all causes and were hospitalized at least once in their last 6 months of life, and non-decedents who were hospitalized between 1/1/2017 and 6/30/2017 and lived 6 or more months after discharge.

Increasing antiretroviral therapy adherence and retention in care among adults living with HIV in Philadelphia: a study protocol for a stepped-wedge cluster-randomised type 2 hybrid effectiveness-implementation trial of managed problem-solving plus (MAPS+) delivered by community health workers.

Introduction: To end the HIV epidemic in Philadelphia, implementation of evidence-based practices (EBP) to increase viral suppression and retention in HIV care is critical. Managed problem solving (MAPS), an EBP for antiretroviral therapy adherence, follows a problem-solving approach to empower people living with HIV (PWH) to manage their health. To overcome barriers to care experienced by PWH in Philadelphia, the EBP was adapted to include a focus on care retention and delivery by community health workers (CHWs).

Nicotine Metabolite Ratio Decreases After Switching Off Efavirenz-Based Therapy in People With HIV Who Smoke.

Rates of cigarette smoking in people with HIV (PWH) are two to three times higher than in people without HIV. Nicotine is metabolized by CYP2A6 and the nicotine metabolite ratio (NMR; 3-hydroxycotinine/cotinine) is a measure of nicotine clearance. Higher NMR has been observed in PWH and is associated with lower quit rates.

The diagnostic likelihood ratio function and modified test for trend: Identifying, evaluating, and validating nontraditional biomarkers in case-control studies.

The ROC curve and its associated summary statistic, the AUC, are used to identify informative diagnostic biomarkers under the assumption that risk of disease is a monotone function of the biomarker. We refer to biomarkers that meet this assumption as traditional, and those that do not as nontraditional. Nontraditional biomarkers most often arise when both low and high biomarker values are associated with an outcome of interest, such as blood pressure with medical complications or leukocyte count with ICU prognosis.

Sociodemographic and Geographic Disparities in End-of-Life Health Care Intensity Among Medicare Beneficiaries With Parkinson Disease.

Background And Objective: Current studies of end-of-life care in Parkinson disease (PD) do not focus on diverse patient samples or provide national views of end-of-life resource utilization. We determined sociodemographic and geographic differences in end-of-life inpatient care intensity among persons with PD in the United States (US).

Methods: This retrospective cohort study included Medicare Part A and Part B beneficiaries 65 years and older with a qualifying PD diagnosis who died between January 1, 2017, and December 31, 2017.